The Study on Constructing Patent Linkage System

• Main Authors: Chun-Miao Chen, 陳春妙
• Other Authors: Wang-Lingc Cheng
• Format: Others
• Language: zh-TW
• Published: 2015
• Online Access: http://ndltd.ncl.edu.tw/handle/50864306435139619679

碩士 === 國立高雄第一科技大學 === 科技法律研究所 === 103 === Recently Taiwan is working hard to participate in Trans-Pacific Partnership Agreement (TPP) and negotiate Free Trade Agreement (FTA) with U.S.A. If Taiwan wants to join TPP or FTA, it is hard to avoid constructing drug marketing and patent linkage system. The patent linkage system exists due to the unique character of drug industry, and the system connects the drug marketing review process with relevant patent status. Drug industry mainly relies on the research development, because of long research and review period of new drugs and high failure risk and cost of research, research achievements are necessary to be protected by IP laws. However, the drugs and hygiene regulations are rather strict, so the manufacturing, marketing, import of drugs have to acquire approval of registration, even though the ingredients identical to approved drugs can be utilized to new indications, they still have to undergo clinical trial to acquire the approval of marketing once again. The cost of the branded drug research is high, but the cost of manufacturing the branded drugs is low, so once the top-selling drug is invented, the branded drug manufacturers could earn great revenue from it which supports the branded drug manufacturers’ operation and subsequent researches. Because drug is easy to duplicate, the branded drug manufacturers highly rely on the exclusive and monopoly right of patent to protect their revenue. Moreover, the branded drug manufacturers utilize the extension of patent term and data protection (or data exclusivity) to maintain their monopoly status. When the term of the branded drug manufacturers’ patent and data protection have expired, the generic drug manufacturers can duplicate the branded drug, so it can lower research cost. Because the branded drug manufacturers can offer new drugs and medicine products, while the generic drug manufacturers can offer lower drug price, both can help execute the disease treatment and public hygiene policy, the public hygiene, intellectual property and the judicial system should take care of the development of the branded and generic drug manufacturers. The goal of the Hatch-Waxman Act is to take care of the branded and generic drug manufacturers to establish a better competitive environment, while the patent linkage is one of the most important systems in the Hatch-Waxman Act, it utilizes the patent information which the branded manufacturers revealed during the new drugs marketing application, while the registered patent information only includes ingredient, dosage form, formulation and usage, if the registered patent information is incorrect, when infringements occurs, the generic drug manufacturers can demand to amend or delete the inappropriate patent information in counterclaim. When the generic drug is applied for marketing, the applicant should claim it to comply with one of the following four conditions: (1) not involved in any patent protection; (2) the term of patent has expired; (3) the patent is valid, but the generic drug will go on to the market until the branded patent has expired; and (4) the patent is invalid or the generic drug does not infringe the patent. If the generic drug complies with the fourth condition during its marketing application and any disputes occur, it should be clarified by courts. Because the unique patent linkage system comes from U.S.A., this thesis would overview the overall of patent linkage system first, and then secondly, would discuss why the patent linkage can be adopted by other countries beyond U.S.A. Moreover, this thesis would introduce the law system and practice of patent linkage in other counties. Last, this thesis would analyze how this system works in Taiwan, and how Taiwan government and industries react to it.